NCT03576131 · ADVERSE EVENTS

Adverse events

GEN1029 (HexaBody®-DR5/DR5) Safety Trial in Patients With Malignant Solid Tumors · Source last updated 2023-08-01

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

Adverse events occurred during the study; they are not necessarily caused by treatment. Serious events are not interchangeable with severe/grade 3–4 events. These safety populations may differ from efficacy populations.

Collection time frame: For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
Other-event reporting threshold: 0%

Participants affected / participants at risk, as reported
Safety group	Serious events	Other events	Deaths
Biweekly Regimen (GEN1029 0.1 mg/kg) Participants received 0.1 mg/kg of GEN1029 every 2 weeks (Q2W) until the end of treatment.	3 / 10	8 / 10	3 / 10
Biweekly Regimen (GEN1029 0.2 mg/kg) Participants received 0.2 mg/kg of GEN1029 Q2W until the end of treatment.	3 / 7	7 / 7	3 / 7
Biweekly Regimen (GEN1029 0.3 mg/kg) Participants received 0.3 mg/kg of GEN1029 Q2W until the end of treatment.	2 / 4	4 / 4	1 / 4
Biweekly Regimen (GEN1029 1.0 mg/kg) Participants received 1.0 mg/kg of GEN1029 Q2W until the end of treatment.	9 / 11	11 / 11	5 / 11
Biweekly Regimen (GEN1029 2.0 mg/kg) Participants received 2.0 mg/kg of GEN1029 Q2W until the end of treatment.	6 / 7	7 / 7	4 / 7
Biweekly Regimen (GEN1029 3.0 mg/kg) Participants received 3.0 mg/kg of GEN1029 Q2W until the end of treatment.	4 / 7	7 / 7	1 / 7
Priming Regimen (GEN1029 0.1 mg/kg) Participants received a priming dose of 0.1 mg/kg of GEN1029 on Cycle 1 Day 1. After 14 days and thereafter once every 14 days, participants received full dose of 0.3 mg/kg until the end of treatment.	0 / 1	1 / 1	0 / 1
Intensified Regimen (GEN1029 1.0 mg/kg) Participants received 1.0 mg/kg of GEN1029 once a week (Q1W) for the first 8 weeks then Q2W until the end of treatment.	1 / 1	1 / 1	1 / 1

Group identifiers: EG000: Biweekly Regimen (GEN1029 0.1 mg/kg) · EG001: Biweekly Regimen (GEN1029 0.2 mg/kg) · EG002: Biweekly Regimen (GEN1029 0.3 mg/kg) · EG003: Biweekly Regimen (GEN1029 1.0 mg/kg) · EG004: Biweekly Regimen (GEN1029 2.0 mg/kg) · EG005: Biweekly Regimen (GEN1029 3.0 mg/kg) · EG006: Priming Regimen (GEN1029 0.1 mg/kg) · EG007: Intensified Regimen (GEN1029 1.0 mg/kg)

Serious adverse events

Event terms and counts are source-reported; expand to read more. A reporting threshold may omit less frequent events.

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA (24.1)
stats
group Id
EG000
num Affected
0
num At Risk
10
num Events
0
group Id
EG001
num Affected
0
num At Risk
7
num Events
0
group Id
EG002
num Affected
1
num At Risk
4
num Events
1
group Id
EG003
num Affected
0
num At Risk
11
num Events
0
group Id
EG004
num Affected
0
num At Risk
7
num Events
0
group Id
EG005
num Affected
0
num At Risk
7
num Events
0
group Id
EG006
num Affected
0
num At Risk
1
num Events
0
group Id
EG007
num Affected
0
num At Risk
1
num Events
0
term
Sinus Tachycardia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (24.1)
stats
group Id
EG000
num Affected
0
num At Risk
10
num Events
0
group Id
EG001
num Affected
0
num At Risk
7
num Events
0
group Id
EG002
num Affected
0
num At Risk
4
num Events
0
group Id
EG003
num Affected
1
num At Risk
11
num Events
1
group Id
EG004
num Affected
0
num At Risk
7
num Events
0
group Id
EG005
num Affected
0
num At Risk
7
num Events
0
group Id
EG006
num Affected
0
num At Risk
1
num Events
0
group Id
EG007
num Affected
0
num At Risk
1
num Events
0
term
Abdominal Pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (24.1)
stats
group Id
EG000
num Affected
0
num At Risk
10
num Events
0
group Id
EG001
num Affected
0
num At Risk
7
num Events
0
group Id
EG002
num Affected
0
num At Risk
4
num Events
0
group Id
EG003
num Affected
1
num At Risk
11
num Events
1
group Id
EG004
num Affected
3
num At Risk
7
num Events
4
group Id
EG005
num Affected
1
num At Risk
7
num Events
1
group Id
EG006
num Affected
0
num At Risk
1
num Events
0
group Id
EG007
num Affected
0
num At Risk
1
num Events
0
term
Diarrhoea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (24.1)
stats
group Id
EG000
num Affected
0
num At Risk
10
num Events
0
group Id
EG001
num Affected
0
num At Risk
7
num Events
0
group Id
EG002
num Affected
0
num At Risk
4
num Events
0
group Id
EG003
num Affected
0
num At Risk
11
num Events
0
group Id
EG004
num Affected
1
num At Risk
7
num Events
1
group Id
EG005
num Affected
0
num At Risk
7
num Events
0
group Id
EG006
num Affected
0
num At Risk
1
num Events
0
group Id
EG007
num Affected
0
num At Risk
1
num Events
0
term
Enteritis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (24.1)
stats
group Id
EG000
num Affected
0
num At Risk
10
num Events
0
group Id
EG001
num Affected
0
num At Risk
7
num Events
0
group Id
EG002
num Affected
0
num At Risk
4
num Events
0
group Id
EG003
num Affected
0
num At Risk
11
num Events
0
group Id
EG004
num Affected
1
num At Risk
7
num Events
1
group Id
EG005
num Affected
0
num At Risk
7
num Events
0
group Id
EG006
num Affected
0
num At Risk
1
num Events
0
group Id
EG007
num Affected
0
num At Risk
1
num Events
0
term
Gastrointestinal Inflammation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (24.1)
stats
group Id
EG000
num Affected
0
num At Risk
10
num Events
0
group Id
EG001
num Affected
0
num At Risk
7
num Events
0
group Id
EG002
num Affected
0
num At Risk
4
num Events
0
group Id
EG003
num Affected
1
num At Risk
11
num Events
1
group Id
EG004
num Affected
0
num At Risk
7
num Events
0
group Id
EG005
num Affected
0
num At Risk
7
num Events
0
group Id
EG006
num Affected
0
num At Risk
1
num Events
0
group Id
EG007
num Affected
0
num At Risk
1
num Events
0
term
Large Intestinal Obstruction
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (24.1)
stats
group Id
EG000
num Affected
0
num At Risk
10
num Events
0
group Id
EG001
num Affected
0
num At Risk
7
num Events
0
group Id
EG002
num Affected
0
num At Risk
4
num Events
0
group Id
EG003
num Affected
0
num At Risk
11
num Events
0
group Id
EG004
num Affected
0
num At Risk
7
num Events
0
group Id
EG005
num Affected
1
num At Risk
7
num Events
1
group Id
EG006
num Affected
0
num At Risk
1
num Events
0
group Id
EG007
num Affected
0
num At Risk
1
num Events
0
term
Nausea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (24.1)
stats
group Id
EG000
num Affected
0
num At Risk
10
num Events
0
group Id
EG001
num Affected
0
num At Risk
7
num Events
0
group Id
EG002
num Affected
0
num At Risk
4
num Events
0
group Id
EG003
num Affected
1
num At Risk
11
num Events
1
group Id
EG004
num Affected
0
num At Risk
7
num Events
0
group Id
EG005
num Affected
0
num At Risk
7
num Events
0
group Id
EG006
num Affected
0
num At Risk
1
num Events
0
group Id
EG007
num Affected
0
num At Risk
1
num Events
0
term
Small Intestinal Obstruction
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (24.1)
stats
group Id
EG000
num Affected
0
num At Risk
10
num Events
0
group Id
EG001
num Affected
0
num At Risk
7
num Events
0
group Id
EG002
num Affected
0
num At Risk
4
num Events
0
group Id
EG003
num Affected
0
num At Risk
11
num Events
0
group Id
EG004
num Affected
0
num At Risk
7
num Events
0
group Id
EG005
num Affected
1
num At Risk
7
num Events
1
group Id
EG006
num Affected
0
num At Risk
1
num Events
0
group Id
EG007
num Affected
0
num At Risk
1
num Events
0
term
Vomiting
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA (24.1)
stats
group Id
EG000
num Affected
0
num At Risk
10
num Events
0
group Id
EG001
num Affected
1
num At Risk
7
num Events
1
group Id
EG002
num Affected
0
num At Risk
4
num Events
0
group Id
EG003
num Affected
0
num At Risk
11
num Events
0
group Id
EG004
num Affected
0
num At Risk
7
num Events
0
group Id
EG005
num Affected
0
num At Risk
7
num Events
0
group Id
EG006
num Affected
0
num At Risk
1
num Events
0
group Id
EG007
num Affected
0
num At Risk
1
num Events
0
term
Fatigue
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA (24.1)
stats
group Id
EG000
num Affected
0
num At Risk
10
num Events
0
group Id
EG001
num Affected
0
num At Risk
7
num Events
0
group Id
EG002
num Affected
0
num At Risk
4
num Events
0
group Id
EG003
num Affected
1
num At Risk
11
num Events
1
group Id
EG004
num Affected
0
num At Risk
7
num Events
0
group Id
EG005
num Affected
0
num At Risk
7
num Events
0
group Id
EG006
num Affected
0
num At Risk
1
num Events
0
group Id
EG007
num Affected
0
num At Risk
1
num Events
0
term
Hernia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA (24.1)
stats
group Id
EG000
num Affected
0
num At Risk
10
num Events
0
group Id
EG001
num Affected
0
num At Risk
7
num Events
0
group Id
EG002
num Affected
1
num At Risk
4
num Events
1
group Id
EG003
num Affected
2
num At Risk
11
num Events
2
group Id
EG004
num Affected
1
num At Risk
7
num Events
1
group Id
EG005
num Affected
1
num At Risk
7
num Events
1
group Id
EG006
num Affected
0
num At Risk
1
num Events
0
group Id
EG007
num Affected
0
num At Risk
1
num Events
0
term
Pyrexia

Other reported adverse events

Event terms and counts are source-reported; expand to read more. A reporting threshold may omit less frequent events.

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA (24.1)
stats
group Id
EG000
num Affected
2
num At Risk
10
num Events
2
group Id
EG001
num Affected
2
num At Risk
7
num Events
2
group Id
EG002
num Affected
1
num At Risk
4
num Events
1
group Id
EG003
num Affected
3
num At Risk
11
num Events
3
group Id
EG004
num Affected
2
num At Risk
7
num Events
2
group Id
EG005
num Affected
1
num At Risk
7
num Events
3
group Id
EG006
num Affected
1
num At Risk
1
num Events
1
group Id
EG007
num Affected
0
num At Risk
1
num Events
0
term
Anaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA (24.1)
stats
group Id
EG000
num Affected
0
num At Risk
10
num Events
0
group Id
EG001
num Affected
0
num At Risk
7
num Events
0
group Id
EG002
num Affected
0
num At Risk
4
num Events
0
group Id
EG003
num Affected
1
num At Risk
11
num Events
1
group Id
EG004
num Affected
0
num At Risk
7
num Events
0
group Id
EG005
num Affected
0
num At Risk
7
num Events
0
group Id
EG006
num Affected
0
num At Risk
1
num Events
0
group Id
EG007
num Affected
0
num At Risk
1
num Events
0
term
Leukocytosis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA (24.1)
stats
group Id
EG000
num Affected
1
num At Risk
10
num Events
3
group Id
EG001
num Affected
0
num At Risk
7
num Events
0
group Id
EG002
num Affected
0
num At Risk
4
num Events
0
group Id
EG003
num Affected
0
num At Risk
11
num Events
0
group Id
EG004
num Affected
0
num At Risk
7
num Events
0
group Id
EG005
num Affected
0
num At Risk
7
num Events
0
group Id
EG006
num Affected
0
num At Risk
1
num Events
0
group Id
EG007
num Affected
0
num At Risk
1
num Events
0
term
Lymphopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA (24.1)
stats
group Id
EG000
num Affected
1
num At Risk
10
num Events
2
group Id
EG001
num Affected
1
num At Risk
7
num Events
1
group Id
EG002
num Affected
0
num At Risk
4
num Events
0
group Id
EG003
num Affected
0
num At Risk
11
num Events
0
group Id
EG004
num Affected
0
num At Risk
7
num Events
0
group Id
EG005
num Affected
0
num At Risk
7
num Events
0
group Id
EG006
num Affected
0
num At Risk
1
num Events
0
group Id
EG007
num Affected
0
num At Risk
1
num Events
0
term
Thrombocytopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA (24.1)
stats
group Id
EG000
num Affected
1
num At Risk
10
num Events
1
group Id
EG001
num Affected
0
num At Risk
7
num Events
0
group Id
EG002
num Affected
0
num At Risk
4
num Events
0
group Id
EG003
num Affected
0
num At Risk
11
num Events
0
group Id
EG004
num Affected
0
num At Risk
7
num Events
0
group Id
EG005
num Affected
0
num At Risk
7
num Events
0
group Id
EG006
num Affected
0
num At Risk
1
num Events
0
group Id
EG007
num Affected
0
num At Risk
1
num Events
0
term
Tachycardia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Ear and labyrinth disorders
source Vocabulary
MedDRA (24.1)
stats
group Id
EG000
num Affected
0
num At Risk
10
num Events
0
group Id
EG001
num Affected
0
num At Risk
7
num Events
0
group Id
EG002
num Affected
0
num At Risk
4
num Events
0
group Id
EG003
num Affected
0
num At Risk
11
num Events
0
group Id
EG004
num Affected
0
num At Risk
7
num Events
0
group Id
EG005
num Affected
0
num At Risk
7
num Events
0
group Id
EG006
num Affected
1
num At Risk
1
num Events
1
group Id
EG007
num Affected
0
num At Risk
1
num Events
0
term
Ear pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Endocrine disorders
source Vocabulary
MedDRA (24.1)
stats
group Id
EG000
num Affected
0
num At Risk
10
num Events
0
group Id
EG001
num Affected
1
num At Risk
7
num Events
1
group Id
EG002
num Affected
0
num At Risk
4
num Events
0
group Id
EG003
num Affected
0
num At Risk
11
num Events
0
group Id
EG004
num Affected
0
num At Risk
7
num Events
0
group Id
EG005
num Affected
0
num At Risk
7
num Events
0
group Id
EG006
num Affected
0
num At Risk
1
num Events
0
group Id
EG007
num Affected
0
num At Risk
1
num Events
0
term
Hypothyroidism
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Eye disorders
source Vocabulary
MedDRA (24.1)
stats
group Id
EG000
num Affected
0
num At Risk
10
num Events
0
group Id
EG001
num Affected
1
num At Risk
7
num Events
1
group Id
EG002
num Affected
0
num At Risk
4
num Events
0
group Id
EG003
num Affected
0
num At Risk
11
num Events
0
group Id
EG004
num Affected
0
num At Risk
7
num Events
0
group Id
EG005
num Affected
0
num At Risk
7
num Events
0
group Id
EG006
num Affected
0
num At Risk
1
num Events
0
group Id
EG007
num Affected
0
num At Risk
1
num Events
0
term
Diplopia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Eye disorders
source Vocabulary
MedDRA (24.1)
stats
group Id
EG000
num Affected
0
num At Risk
10
num Events
0
group Id
EG001
num Affected
0
num At Risk
7
num Events
0
group Id
EG002
num Affected
0
num At Risk
4
num Events
0
group Id
EG003
num Affected
0
num At Risk
11
num Events
0
group Id
EG004
num Affected
0
num At Risk
7
num Events
0
group Id
EG005
num Affected
1
num At Risk
7
num Events
1
group Id
EG006
num Affected
0
num At Risk
1
num Events
0
group Id
EG007
num Affected
0
num At Risk
1
num Events
0
term
Extraocular muscle paresis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Eye disorders
source Vocabulary
MedDRA (24.1)
stats
group Id
EG000
num Affected
1
num At Risk
10
num Events
1
group Id
EG001
num Affected
0
num At Risk
7
num Events
0
group Id
EG002
num Affected
0
num At Risk
4
num Events
0
group Id
EG003
num Affected
0
num At Risk
11
num Events
0
group Id
EG004
num Affected
0
num At Risk
7
num Events
0
group Id
EG005
num Affected
0
num At Risk
7
num Events
0
group Id
EG006
num Affected
0
num At Risk
1
num Events
0
group Id
EG007
num Affected
0
num At Risk
1
num Events
0
term
Eye pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Eye disorders
source Vocabulary
MedDRA (24.1)
stats
group Id
EG000
num Affected
1
num At Risk
10
num Events
1
group Id
EG001
num Affected
0
num At Risk
7
num Events
0
group Id
EG002
num Affected
0
num At Risk
4
num Events
0
group Id
EG003
num Affected
0
num At Risk
11
num Events
0
group Id
EG004
num Affected
0
num At Risk
7
num Events
0
group Id
EG005
num Affected
0
num At Risk
7
num Events
0
group Id
EG006
num Affected
0
num At Risk
1
num Events
0
group Id
EG007
num Affected
0
num At Risk
1
num Events
0
term
Visual impairment
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (24.1)
stats
group Id
EG000
num Affected
0
num At Risk
10
num Events
0
group Id
EG001
num Affected
0
num At Risk
7
num Events
0
group Id
EG002
num Affected
0
num At Risk
4
num Events
0
group Id
EG003
num Affected
1
num At Risk
11
num Events
1
group Id
EG004
num Affected
0
num At Risk
7
num Events
0
group Id
EG005
num Affected
0
num At Risk
7
num Events
0
group Id
EG006
num Affected
0
num At Risk
1
num Events
0
group Id
EG007
num Affected
0
num At Risk
1
num Events
0
term
Abdominal discomfort

Complete source fields

event Groups

deaths Num Affected
3
deaths Num At Risk
10
description
Participants received 0.1 mg/kg of GEN1029 every 2 weeks (Q2W) until the end of treatment.
id
EG000
other Num Affected
8
other Num At Risk
10
serious Num Affected
3
serious Num At Risk
10
title
Biweekly Regimen (GEN1029 0.1 mg/kg)
deaths Num Affected
3
deaths Num At Risk
7
description
Participants received 0.2 mg/kg of GEN1029 Q2W until the end of treatment.
id
EG001
other Num Affected
7
other Num At Risk
7
serious Num Affected
3
serious Num At Risk
7
title
Biweekly Regimen (GEN1029 0.2 mg/kg)
deaths Num Affected
1
deaths Num At Risk
4
description
Participants received 0.3 mg/kg of GEN1029 Q2W until the end of treatment.
id
EG002
other Num Affected
4
other Num At Risk
4
serious Num Affected
2
serious Num At Risk
4
title
Biweekly Regimen (GEN1029 0.3 mg/kg)
deaths Num Affected
5
deaths Num At Risk
11
description
Participants received 1.0 mg/kg of GEN1029 Q2W until the end of treatment.
id
EG003
other Num Affected
11
other Num At Risk
11
serious Num Affected
9
serious Num At Risk
11
title
Biweekly Regimen (GEN1029 1.0 mg/kg)
deaths Num Affected
4
deaths Num At Risk
7
description
Participants received 2.0 mg/kg of GEN1029 Q2W until the end of treatment.
id
EG004
other Num Affected
7
other Num At Risk
7
serious Num Affected
6
serious Num At Risk
7
title
Biweekly Regimen (GEN1029 2.0 mg/kg)
deaths Num Affected
1
deaths Num At Risk
7
description
Participants received 3.0 mg/kg of GEN1029 Q2W until the end of treatment.
id
EG005
other Num Affected
7
other Num At Risk
7
serious Num Affected
4
serious Num At Risk
7
title
Biweekly Regimen (GEN1029 3.0 mg/kg)
deaths Num Affected
0
deaths Num At Risk
1
description
Participants received a priming dose of 0.1 mg/kg of GEN1029 on Cycle 1 Day 1. After 14 days and thereafter once every 14 days, participants received full dose of 0.3 mg/kg until the end of treatment.
id
EG006
other Num Affected
1
other Num At Risk
1
serious Num Affected
0
serious Num At Risk
1
title
Priming Regimen (GEN1029 0.1 mg/kg)
deaths Num Affected
1
deaths Num At Risk
1
description
Participants received 1.0 mg/kg of GEN1029 once a week (Q1W) for the first 8 weeks then Q2W until the end of treatment.
id
EG007
other Num Affected
1
other Num At Risk
1
serious Num Affected
1
serious Num At Risk
1
title
Intensified Regimen (GEN1029 1.0 mg/kg)

frequency Threshold

other Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA (24.1)
stats
group Id
EG000
num Affected
2
num At Risk
10
num Events
2
group Id
EG001
num Affected
2
num At Risk
7
num Events
2
group Id
EG002
num Affected
1
num At Risk
4
num Events
1
group Id
EG003
num Affected
3
num At Risk
11
num Events
3
group Id
EG004
num Affected
2
num At Risk
7
num Events
2
group Id
EG005
num Affected
1
num At Risk
7
num Events
3
group Id
EG006
num Affected
1
num At Risk
1
num Events
1
group Id
EG007
num Affected
0
num At Risk
1
num Events
0
term
Anaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA (24.1)
stats
group Id
EG000
num Affected
0
num At Risk
10
num Events
0
group Id
EG001
num Affected
0
num At Risk
7
num Events
0
group Id
EG002
num Affected
0
num At Risk
4
num Events
0
group Id
EG003
num Affected
1
num At Risk
11
num Events
1
group Id
EG004
num Affected
0
num At Risk
7
num Events
0
group Id
EG005
num Affected
0
num At Risk
7
num Events
0
group Id
EG006
num Affected
0
num At Risk
1
num Events
0
group Id
EG007
num Affected
0
num At Risk
1
num Events
0
term
Leukocytosis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA (24.1)
stats
group Id
EG000
num Affected
1
num At Risk
10
num Events
3
group Id
EG001
num Affected
0
num At Risk
7
num Events
0
group Id
EG002
num Affected
0
num At Risk
4
num Events
0
group Id
EG003
num Affected
0
num At Risk
11
num Events
0
group Id
EG004
num Affected
0
num At Risk
7
num Events
0
group Id
EG005
num Affected
0
num At Risk
7
num Events
0
group Id
EG006
num Affected
0
num At Risk
1
num Events
0
group Id
EG007
num Affected
0
num At Risk
1
num Events
0
term
Lymphopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA (24.1)
stats
group Id
EG000
num Affected
1
num At Risk
10
num Events
2
group Id
EG001
num Affected
1
num At Risk
7
num Events
1
group Id
EG002
num Affected
0
num At Risk
4
num Events
0
group Id
EG003
num Affected
0
num At Risk
11
num Events
0
group Id
EG004
num Affected
0
num At Risk
7
num Events
0
group Id
EG005
num Affected
0
num At Risk
7
num Events
0
group Id
EG006
num Affected
0
num At Risk
1
num Events
0
group Id
EG007
num Affected
0
num At Risk
1
num Events
0
term
Thrombocytopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA (24.1)
stats
group Id
EG000
num Affected
1
num At Risk
10
num Events
1
group Id
EG001
num Affected
0
num At Risk
7
num Events
0
group Id
EG002
num Affected
0
num At Risk
4
num Events
0
group Id
EG003
num Affected
0
num At Risk
11
num Events
0
group Id
EG004
num Affected
0
num At Risk
7
num Events
0
group Id
EG005
num Affected
0
num At Risk
7
num Events
0
group Id
EG006
num Affected
0
num At Risk
1
num Events
0
group Id
EG007
num Affected
0
num At Risk
1
num Events
0
term
Tachycardia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Ear and labyrinth disorders
source Vocabulary
MedDRA (24.1)
stats
group Id
EG000
num Affected
0
num At Risk
10
num Events
0
group Id
EG001
num Affected
0
num At Risk
7
num Events
0
group Id
EG002
num Affected
0
num At Risk
4
num Events
0
group Id
EG003
num Affected
0
num At Risk
11
num Events
0
group Id
EG004
num Affected
0
num At Risk
7
num Events
0
group Id
EG005
num Affected
0
num At Risk
7
num Events
0
group Id
EG006
num Affected
1
num At Risk
1
num Events
1
group Id
EG007
num Affected
0
num At Risk
1
num Events
0
term
Ear pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Endocrine disorders
source Vocabulary
MedDRA (24.1)
stats
group Id
EG000
num Affected
0
num At Risk
10
num Events
0
group Id
EG001
num Affected
1
num At Risk
7
num Events
1
group Id
EG002
num Affected
0
num At Risk
4
num Events
0
group Id
EG003
num Affected
0
num At Risk
11
num Events
0
group Id
EG004
num Affected
0
num At Risk
7
num Events
0
group Id
EG005
num Affected
0
num At Risk
7
num Events
0
group Id
EG006
num Affected
0
num At Risk
1
num Events
0
group Id
EG007
num Affected
0
num At Risk
1
num Events
0
term
Hypothyroidism
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Eye disorders
source Vocabulary
MedDRA (24.1)
stats
group Id
EG000
num Affected
0
num At Risk
10
num Events
0
group Id
EG001
num Affected
1
num At Risk
7
num Events
1
group Id
EG002
num Affected
0
num At Risk
4
num Events
0
group Id
EG003
num Affected
0
num At Risk
11
num Events
0
group Id
EG004
num Affected
0
num At Risk
7
num Events
0
group Id
EG005
num Affected
0
num At Risk
7
num Events
0
group Id
EG006
num Affected
0
num At Risk
1
num Events
0
group Id
EG007
num Affected
0
num At Risk
1
num Events
0
term
Diplopia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Eye disorders
source Vocabulary
MedDRA (24.1)
stats
group Id
EG000
num Affected
0
num At Risk
10
num Events
0
group Id
EG001
num Affected
0
num At Risk
7
num Events
0
group Id
EG002
num Affected
0
num At Risk
4
num Events
0
group Id
EG003
num Affected
0
num At Risk
11
num Events
0
group Id
EG004
num Affected
0
num At Risk
7
num Events
0
group Id
EG005
num Affected
1
num At Risk
7
num Events
1
group Id
EG006
num Affected
0
num At Risk
1
num Events
0
group Id
EG007
num Affected
0
num At Risk
1
num Events
0
term
Extraocular muscle paresis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Eye disorders
source Vocabulary
MedDRA (24.1)
stats
group Id
EG000
num Affected
1
num At Risk
10
num Events
1
group Id
EG001
num Affected
0
num At Risk
7
num Events
0
group Id
EG002
num Affected
0
num At Risk
4
num Events
0
group Id
EG003
num Affected
0
num At Risk
11
num Events
0
group Id
EG004
num Affected
0
num At Risk
7
num Events
0
group Id
EG005
num Affected
0
num At Risk
7
num Events
0
group Id
EG006
num Affected
0
num At Risk
1
num Events
0
group Id
EG007
num Affected
0
num At Risk
1
num Events
0
term
Eye pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Eye disorders
source Vocabulary
MedDRA (24.1)
stats
group Id
EG000
num Affected
1
num At Risk
10
num Events
1
group Id
EG001
num Affected
0
num At Risk
7
num Events
0
group Id
EG002
num Affected
0
num At Risk
4
num Events
0
group Id
EG003
num Affected
0
num At Risk
11
num Events
0
group Id
EG004
num Affected
0
num At Risk
7
num Events
0
group Id
EG005
num Affected
0
num At Risk
7
num Events
0
group Id
EG006
num Affected
0
num At Risk
1
num Events
0
group Id
EG007
num Affected
0
num At Risk
1
num Events
0
term
Visual impairment
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (24.1)
stats
group Id
EG000
num Affected
0
num At Risk
10
num Events
0
group Id
EG001
num Affected
0
num At Risk
7
num Events
0
group Id
EG002
num Affected
0
num At Risk
4
num Events
0
group Id
EG003
num Affected
1
num At Risk
11
num Events
1
group Id
EG004
num Affected
0
num At Risk
7
num Events
0
group Id
EG005
num Affected
0
num At Risk
7
num Events
0
group Id
EG006
num Affected
0
num At Risk
1
num Events
0
group Id
EG007
num Affected
0
num At Risk
1
num Events
0
term
Abdominal discomfort

serious Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA (24.1)
stats
group Id
EG000
num Affected
0
num At Risk
10
num Events
0
group Id
EG001
num Affected
0
num At Risk
7
num Events
0
group Id
EG002
num Affected
1
num At Risk
4
num Events
1
group Id
EG003
num Affected
0
num At Risk
11
num Events
0
group Id
EG004
num Affected
0
num At Risk
7
num Events
0
group Id
EG005
num Affected
0
num At Risk
7
num Events
0
group Id
EG006
num Affected
0
num At Risk
1
num Events
0
group Id
EG007
num Affected
0
num At Risk
1
num Events
0
term
Sinus Tachycardia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (24.1)
stats
group Id
EG000
num Affected
0
num At Risk
10
num Events
0
group Id
EG001
num Affected
0
num At Risk
7
num Events
0
group Id
EG002
num Affected
0
num At Risk
4
num Events
0
group Id
EG003
num Affected
1
num At Risk
11
num Events
1
group Id
EG004
num Affected
0
num At Risk
7
num Events
0
group Id
EG005
num Affected
0
num At Risk
7
num Events
0
group Id
EG006
num Affected
0
num At Risk
1
num Events
0
group Id
EG007
num Affected
0
num At Risk
1
num Events
0
term
Abdominal Pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (24.1)
stats
group Id
EG000
num Affected
0
num At Risk
10
num Events
0
group Id
EG001
num Affected
0
num At Risk
7
num Events
0
group Id
EG002
num Affected
0
num At Risk
4
num Events
0
group Id
EG003
num Affected
1
num At Risk
11
num Events
1
group Id
EG004
num Affected
3
num At Risk
7
num Events
4
group Id
EG005
num Affected
1
num At Risk
7
num Events
1
group Id
EG006
num Affected
0
num At Risk
1
num Events
0
group Id
EG007
num Affected
0
num At Risk
1
num Events
0
term
Diarrhoea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (24.1)
stats
group Id
EG000
num Affected
0
num At Risk
10
num Events
0
group Id
EG001
num Affected
0
num At Risk
7
num Events
0
group Id
EG002
num Affected
0
num At Risk
4
num Events
0
group Id
EG003
num Affected
0
num At Risk
11
num Events
0
group Id
EG004
num Affected
1
num At Risk
7
num Events
1
group Id
EG005
num Affected
0
num At Risk
7
num Events
0
group Id
EG006
num Affected
0
num At Risk
1
num Events
0
group Id
EG007
num Affected
0
num At Risk
1
num Events
0
term
Enteritis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (24.1)
stats
group Id
EG000
num Affected
0
num At Risk
10
num Events
0
group Id
EG001
num Affected
0
num At Risk
7
num Events
0
group Id
EG002
num Affected
0
num At Risk
4
num Events
0
group Id
EG003
num Affected
0
num At Risk
11
num Events
0
group Id
EG004
num Affected
1
num At Risk
7
num Events
1
group Id
EG005
num Affected
0
num At Risk
7
num Events
0
group Id
EG006
num Affected
0
num At Risk
1
num Events
0
group Id
EG007
num Affected
0
num At Risk
1
num Events
0
term
Gastrointestinal Inflammation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (24.1)
stats
group Id
EG000
num Affected
0
num At Risk
10
num Events
0
group Id
EG001
num Affected
0
num At Risk
7
num Events
0
group Id
EG002
num Affected
0
num At Risk
4
num Events
0
group Id
EG003
num Affected
1
num At Risk
11
num Events
1
group Id
EG004
num Affected
0
num At Risk
7
num Events
0
group Id
EG005
num Affected
0
num At Risk
7
num Events
0
group Id
EG006
num Affected
0
num At Risk
1
num Events
0
group Id
EG007
num Affected
0
num At Risk
1
num Events
0
term
Large Intestinal Obstruction
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (24.1)
stats
group Id
EG000
num Affected
0
num At Risk
10
num Events
0
group Id
EG001
num Affected
0
num At Risk
7
num Events
0
group Id
EG002
num Affected
0
num At Risk
4
num Events
0
group Id
EG003
num Affected
0
num At Risk
11
num Events
0
group Id
EG004
num Affected
0
num At Risk
7
num Events
0
group Id
EG005
num Affected
1
num At Risk
7
num Events
1
group Id
EG006
num Affected
0
num At Risk
1
num Events
0
group Id
EG007
num Affected
0
num At Risk
1
num Events
0
term
Nausea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (24.1)
stats
group Id
EG000
num Affected
0
num At Risk
10
num Events
0
group Id
EG001
num Affected
0
num At Risk
7
num Events
0
group Id
EG002
num Affected
0
num At Risk
4
num Events
0
group Id
EG003
num Affected
1
num At Risk
11
num Events
1
group Id
EG004
num Affected
0
num At Risk
7
num Events
0
group Id
EG005
num Affected
0
num At Risk
7
num Events
0
group Id
EG006
num Affected
0
num At Risk
1
num Events
0
group Id
EG007
num Affected
0
num At Risk
1
num Events
0
term
Small Intestinal Obstruction
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (24.1)
stats
group Id
EG000
num Affected
0
num At Risk
10
num Events
0
group Id
EG001
num Affected
0
num At Risk
7
num Events
0
group Id
EG002
num Affected
0
num At Risk
4
num Events
0
group Id
EG003
num Affected
0
num At Risk
11
num Events
0
group Id
EG004
num Affected
0
num At Risk
7
num Events
0
group Id
EG005
num Affected
1
num At Risk
7
num Events
1
group Id
EG006
num Affected
0
num At Risk
1
num Events
0
group Id
EG007
num Affected
0
num At Risk
1
num Events
0
term
Vomiting
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA (24.1)
stats
group Id
EG000
num Affected
0
num At Risk
10
num Events
0
group Id
EG001
num Affected
1
num At Risk
7
num Events
1
group Id
EG002
num Affected
0
num At Risk
4
num Events
0
group Id
EG003
num Affected
0
num At Risk
11
num Events
0
group Id
EG004
num Affected
0
num At Risk
7
num Events
0
group Id
EG005
num Affected
0
num At Risk
7
num Events
0
group Id
EG006
num Affected
0
num At Risk
1
num Events
0
group Id
EG007
num Affected
0
num At Risk
1
num Events
0
term
Fatigue
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA (24.1)
stats
group Id
EG000
num Affected
0
num At Risk
10
num Events
0
group Id
EG001
num Affected
0
num At Risk
7
num Events
0
group Id
EG002
num Affected
0
num At Risk
4
num Events
0
group Id
EG003
num Affected
1
num At Risk
11
num Events
1
group Id
EG004
num Affected
0
num At Risk
7
num Events
0
group Id
EG005
num Affected
0
num At Risk
7
num Events
0
group Id
EG006
num Affected
0
num At Risk
1
num Events
0
group Id
EG007
num Affected
0
num At Risk
1
num Events
0
term
Hernia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA (24.1)
stats
group Id
EG000
num Affected
0
num At Risk
10
num Events
0
group Id
EG001
num Affected
0
num At Risk
7
num Events
0
group Id
EG002
num Affected
1
num At Risk
4
num Events
1
group Id
EG003
num Affected
2
num At Risk
11
num Events
2
group Id
EG004
num Affected
1
num At Risk
7
num Events
1
group Id
EG005
num Affected
1
num At Risk
7
num Events
1
group Id
EG006
num Affected
0
num At Risk
1
num Events
0
group Id
EG007
num Affected
0
num At Risk
1
num Events
0
term
Pyrexia

time Frame

For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)

Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f

Preserved source evidence · Not medical advice